​  ​​​​​​DTILaboratories, Inc.

Between-Run Precision Between-run precision was determined by performing a series of duplicate measurements of two different samples over a series of twenty different runs (n=20). Both whole blood (WB) and capillary blood (CB) are presented.Type your paragraph here.

Total Error DeterminationTotal error is a measurement of the overall analytical performance of an assay, and combines both accuracy and precision. Total error is equal to the % Bias of the DTI Laboratories Hemoglobin Capillary A1c assay was calculated using the linear regression formula, derived from the comparison of the capillary % HbA1c assay versus the comparable whole blood methodology. Total CV = 0.09 (CVC 2 + CV WB 2)½.The results of the total error analysis for the DTI capillary % A1c assay at both normal and highly elevated % A1c levels are presented below.

Correlation Coefficient          0.992
Slope                                         .980

Intercept                                 0.988

Mean % A1c             6.0                6.0

​% A1c Range           3.2-19.4         3.2 -20.1

Standard

Deviation A1c            1.2                    1.0

DTI Laboratories, Inc.

Technical Bulletin
Capillary Hemoglobin A1c
Performance Characteristics 

    Mean            Standard          % Coefficient
    % A1c           Deviation       of Variation (CV
's)        3.2 (CB)            0.02                  .051%
   6.0 (CB)             0.01                   .059%  

 14.6 (CB)             0.08                   .091%
  4.0 (WB)             0.02                   .065%
  7.6 (WB)             0.011                   1.0%

15.0 (WB)             0.085                 .069%

                            Capillary       Venous 

                            Blood            Blood

% A1c                  % Bias    Total        Total Error

Concentration                     % CV       % (HbA1c)
 3.2%                          0.2       1.4%           ± 0.12%

  6.0%                         0.1        1.3%          ± 0.11%

  7.6%                         0.1        0.8%          ± 0.09%

14.6%                         0.2        1.6%          ± 0.15%

 Mean           Standard          % Coefficient
 % A1c          Deviation       of Variation (CV's)  

  3.2 (CB)           0.01                    1.3%
  6.0 (CB)           0.02                    1.2%

14.6 (CB)           0.02                    1.4%
  4.0 (WB)          0.05                    1.1%
  7.6 (WB)          0.06                    1.2%
15.0 (WB)          0.05                    1.3%

DTI Laboratories, Inc.
PO Box 1954

Thomasville, GA  31799-1954
Date Submitted: 1/1/2002

WB/CB Comparison

Within-Run Precision Within-run was determined by assaying capillary collected samples containing various concentrations of Hemoglobin A1c. Each sample was assayed in replicates of two in twenty different runs. Both whole blood (WB) and capillary data are presented for comparison below.

Expected Values A population of 165 non-diabetic individuals were analyzed using the capillary % A1c methodology. The expected values generated utilizing these values are presented below.        

                         Lower Limit         Upper Limit
                           of % A1c            of % A1c
Expected Values     4.2%                   5.9%
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Linearity of procedure/methodology

(HPLC-IE/BA Linearity range of assay: 3.0% - 30.0%. Specimen Requirements Capillary blood collection requires 10 μl drop of capillary blood. The blood is placed in a 1 ml vial of EDTA/.025KCN,


Specimen Stability Capillary A1c blood samples are stable for 30 days or more. Samples were tested at a following number of days in transit and thresholds of environmental temperatures.


                           Mean Capillary     Bias

Days                       % A1c             (%)

1                                   9.0                    0.0             

5-6                                9.0                    0.0

7-14                              9.0                    0.0

15-21                            9.1                 + 0.1 

22-30                            9.1                  +0.1


Temperature Threshold Study

Temperature indicator failure strips were applied to sample containers containing two levels of

A1c capillary samples. The following demonstrates the results of temperature variation of the

Temperature                         Observed         % 

Indicator Strips      % A1c       Results       Variance

130° F                        6.0              5.0               -1.00 125° F                        6.0              5.9              - 0.10 130° F                      14.0            12.0              - 2.00

125° F                      14.0            13.8               -.200

- 20° F                         6.0              5.3              - 0.70 -10° F                          6.0              5.8              -.200

- 20° F                       14.0            13.2             - .800 -10° F                        14.0            13.8             - .200

% A1c values. Known values at 6.0% and 14.0% were applied.


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Accuracy Paired whole blood (venous/vein) and EDTA capillary samples containing a variety of concentrations of HbA1c were analyzed. Percent (%) HbA1c concentrations observed for capillary samples versus EDTA whole blood (vein) samples were analyzed by linear regression.